Background
Data on antithrombotic therapy after percutaneous left atrial appendage occlusion (LAAO) is scarce and no randomized evaluation has been performed to demonstrate what is the best ...antithrombotic strategy. Up to date, different antithrombotic regimens with variable durations are currently used. In fact, the use of oral anticoagulation (OAC) or dual antiplatelet therapy (DAPT) with aspirin and clopidogrel during the initial phase (∓ 3 months post-LAAO) has been proposed as valid strategies. However, antiplatelet and OAC therapies have never been compared in a randomized study after left atrial appendage closure (LAAC). The purpose of the present study is to ascertain an optimal antithrombotic strategy after LAAC in terms of safety and efficacy. The study will compare a novel OAC (NOAC) with a highly safety profile like apixaban 5 mg/12 h or 2.5 mg/12 h (after dose adjustment or in high-risk patients) with standard antiplatelet therapy with DAPT. The aim of the study was to compare a strategy of anticoagulation with apixaban 5 mg/2.5 mg bid to the current standard of care (DAPT with aspirin and clopidogrel) after LAAO in patients with non-valvular atrial fibrillation (AF).
Methods
This is a phase IV multicenter randomized, open-label, controlled trial comparing the efficacy and safety of apixaban vs. DAPT after LAAO, both for 3 months. The primary endpoint is a combined endpoint of death, myocardial infarction, stroke, thromboembolic complications, and major or significant bleeding at 3 months of follow-up. Approximately 160 subjects will be enrolled and followed 12 months from randomization.
Conclusions
Considering the high risk of both thromboembolic and hemorrhagic events of patients undergoing LAAO, establishment of an appropriate antithrombotic therapy in terms of efficacy and safety after LAAO is of vital importance.
Trial registration
EudraCT number: 2018-001013-32
Background . Chronic total occlusion (CTO) plaque modification (CTO‐PM) is often used for unsuccessful CTO interventions. Methods . A multicenter, prospective study included consecutive patients with ...failed CTO recanalization. At the end of the failed procedure, patients received either a conventional (CB) or drug‐coated balloon (DCB) for CTO‐PM at the operator’s discretion and underwent a new attempt of CTO recanalization ∼3 months later. Results . A total of 55 patients were enrolled (DCB: 22; CB: 33), with a median age of 66 years. The median J‐score was 3, and CCS angina classes III–IV were present in 45% of the patients. After the first CTO‐PCI attempt, no in‐hospital cardiac deaths were registered. The overall rate of in‐hospital myocardial infarction was 3.6%, without significant differences between the DCB and CB groups (4.5% after DCB vs 3.0% after CB, p = 0.999). The success rate of the second CTO‐PCI attempt was 86.8%, with a periprocedural complication rate of 5.7% and with an overall rate of in‐hospital complications of 24.5%, without significant differences between the 2 groups (13.6% in the DCB group vs 32.2% in the CB group, p = 0.195). Compared with CB, in the DCB group, the second CTO‐PCI required a shorter median fluoroscopy time (33 vs 60 min, p < 0.001), a lower contrast volume (170 vs 321 cc, p < 0.001), and a lower radiation dose (1.7 vs 3.3 Gy, p < 0.001). At 1‐year follow‐up, outcomes were comparable between the 2 strategies, target vessel failure occurred in 5.7% and major adverse cardiovascular events in 18.2% (13.6% in the DCB group vs 21.2% in the CB group, p = 0.494). Conclusions . PM after CTO recanalization failure is safe and warrants high success rates when a second attempt is performed. A DCB strategy for CTO‐PM does not seem to ensure higher success or better clinical outcomes, but its use was associated with simpler staged procedures. This trial is registered with NCT05158686 .
...single antiplatelet therapy after LAAC in patients with a high risk of bleeding is associated with a low rate of cardioembolic and bleeding complications at a median follow-up of 19 months. ...Watchman (Boston Scientific, Natick, Massachusetts); Amplatzer Cardiac Plug/Amulet (St. Jude Medical, Minneapolis, Minnesota).CHA2DS2-VASc = congestive heart failure, hypertension, age >=75 years, diabetes mellitus, prior stroke, transient ischemic attack, or thromboembolism, vascular disease, age 65-74 years, sex category (female); CHADS2 = congestive heart failure, hypertension, age >=75 years, diabetes mellitus, prior stroke or transient ischemic attack; HAS-BLED = hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol; LAA = left atrial appendage; TEE = transesophageal echocardiography; TIA = transient ischemic attack.
Left atrial appendage occlusion (LAAO) is emerging as a promising alternative to oral anticoagulation. Because aged patients present a greater risk of not only cardioembolic events but also major ...bleeding, LAAO might represent a valid alternative as this would allow oral anticoagulation cessation while keeping cardioembolic protection. The objective of the study was to explore the safety and efficacy of LAAO in elderly patients. Data from the AMPLATZER Cardiac Plug multicenter registry were analyzed. The cohort was categorized in 2 groups (<75 vs ≥75 years). A total of 1,053 subjects were included in the registry. Of them, 219 were excluded because of combined procedures. As a result, 828 subjects were included (54.6% ≥75 years). Procedural success was high and similar in both groups (97.3%). Acute procedural major adverse events were not statistically different among groups (3.2% in <75 years vs 5.1%; p = 0.17) although stratified analysis showed a higher incidence of cardiac tamponade in elderly patients (0.5% vs 2.2%; p = 0.04). With a median follow-up of 16.8 months, no significant differences in stroke/TIA (1.9% vs 2.3%; p = 0.89) and major bleeding (1.7% vs 2.6%; p = 0.54) were observed. In conclusion, LAAO was associated with similar procedural success in patients aged <75 and ≥75 years although older patients had a higher incidence of cardiac tamponade. At follow-up, stroke and major bleeding rates were similar among groups.
Abstract The mobilization pattern and functionality of endothelial progenitor cells after an acute ischemic event remain largely unknown. The aim of our study was to characterize and compare the ...short- and long-term mobilization of endothelial progenitor cells and circulating endothelial cells after acute myocardial infarction or atherothrombotic stroke, and to determine the relationship between these cell counts and plasma concentrations of vascular cell adhesion molecule (VCAM-1) and Von Willebrand factor (VWF) as surrogate markers of endothelial damage and inflammation. In addition, we assessed whether endothelial progenitor cells behave like functional endothelial cells. We included 150 patients with acute myocardial infarction or atherothrombotic stroke and 145 controls. Endothelial progenitor cells CD45 −, CD34 +, KDR +, CD133 +, circulating endothelial cells CD45 −, CD146 +, CD31 +, VWF, and VCAM-1 levels were measured in controls (baseline only) and in patients within 24 h (baseline) and at 7, 30, and 180 days after the event. Myocardial infarction patients had higher counts of endothelial progenitor cells and circulating endothelial cells than the controls (201.0/mL vs. 57.0/mL; p < 0.01 and 181.0/mL vs. 62.0/mL; p < 0.01). Endothelial progenitor cells peaked at 30 days post-infarction (201.0/mL vs. 369.5/mL; p < 0.01), as did VCAM-1 (573.7 ng/mL vs. 701.8 ng/mL; p < 0.01). At 180 days post-infarction, circulating endothelial cells and VWF decreased, compared to baseline. In stroke patients, the number of endothelial progenitor cells — but not circulating endothelial cells — was higher than in controls (90.0/mL vs. 37.0/mL; p = 0.01; 105.0/mL vs. 71.0/mL; p = 0.11). At 30 days after stroke, however, VCAM-1 peaked (628.1/mL vs. 869.1/mL; p < 0.01) but there was no significant change in endothelial progenitor cells (90/mL vs. 78/mL; p < 0.34). At 180 days after stroke, circulating endothelial cells and VWF decreased, compared to baseline. Cultured endothelial progenitor cells from controls and myocardial infarction patients had endothelial phenotype characteristics and exhibited functional differences in adhesion and Ca 2 + influx, but not in proliferation and vasculogenesis. In myocardial infarction patients, VCAM-1 levels and mobilization of endothelial progenitor cells peaked at 30 days after the ischemic event. Although a similar VCAM-1 kinetic was observed in stroke patients, endothelial progenitor cells did not increase. Endothelial progenitor cells had mature endothelial capabilities in vitro.
The optimal antithrombotic strategy following left atrial appendage occlusion (LAAO) is not yet clearly established. Low-dose non-vitamin K antagonist oral anticoagulants (NOAC) might represent a ...valid alternative, but data regarding their usage is scarce. The aim of this study was to examine the efficacy and safety of low-dose NOAC compared to single (SAPT) or dual antiplatelet therapies (DAPT) after LAAO. We included consecutive patients with non-valvular atrial fibrillation who underwent LAAO and received low-dose apixaban, SAPT, or DAPT at discharge. The primary objective of this study included an efficacy endpoint (thromboembolic events and device related thrombosis (DRT)) and a safety endpoint (incidence of major bleeding) within the first three months after LAAO. A total of 139 patients were included. This group involved SAPT in 26 (18%), DAPT in 73 (53%), and apixaban in 40 (29%) patients. Follow-up at three-months showed no significant differences in the primary efficacy endpoint (2 (8%) SAPT, 3 (4%) DAPT and 0 (0%) apixaban; p value = 0.25). In contrast, the primary safety endpoint occurred more frequently in DAPT patients (7 (10%) DAPT, 0 (0%), SAPT and 0 with apixaban; p value = 0.03). Combining both efficacy and safety outcomes, low dose apixaban had a lower rate of events (2 (8%) with SAPT, 9 (12%) with DAPT and 0 (0%) with apixaban; p = 0.046). Low-dose apixaban after LAAO may be a valid alternative to DAPT and SAPT as depicted by the reduction in the occurrence of major bleedings and combined DRT/major bleedings respectively. Randomized data will be necessary to validate this strategy.
Background
Thrombocytopenia after transcatheter aortic valve implantation (TAVI) is common and has been related to higher mortality and major complications. No comparison between balloon‐expandable ...(BEV) and self‐expanding valves (SEV) regarding drop platelet count (DPC) has been reported to date. The objectives of this study were to analyze the differences in DPC between BEVs or SEVs and their prognostic implications in clinical outcomes.
Methods
We retrospectively analyzed patients undergoing TAVI. Platelet counts after TAVI were collected. Two groups were created: DPC ≤ 30% and DPC > 30%. VARC‐2 criteria were used to define outcomes.
Results
Study population was composed of 195 patients (age 77.5 ± 6.7, 57.4% males). All of them but one experienced DPC (mean DPC 31.9 ± 15.3%). DPC was significantly higher among the patients treated with BEV compared to those treated with SEV (36.3 ± 15.1% vs 27.7 ± 14.4, P < 0.001). After multivariate analysis, the use of BEV was independently associated with a higher rate of DPC > 30% (67.4% vs 36.0%; OR 3.4; 95% CI, 1.42‐8.16). At 30 days, the DPC > 30% was associated with a higher rate of life‐threatening/major bleeding, major vascular complications, in‐hospital sepsis and mortality. At one year, there were no statistically significant differences in the mortality rate between groups (6.35% vs 10.0%, HR 1.54; 95% CI, 0.56–4.25).
Conclusions
In this study, the use of BEV was associated with a higher risk of DPC after TAVI. A DPC rate > 30% was associated with an increased risk of major complications at 30 days.
Coronary obstruction (CO) is a rare but potentially fatal complication of transcatheter aortic valve implantation (TAVI). The present article aims to summarize the evidence on CO risk factors and ...provide an overview of preventive strategies. We performed a comprehensive literature review focused on these items. The analysis included studies addressing patient-specific characteristics, procedural aspects, and the effectiveness of various prevention techniques in mitigating CO risk. Specific risk factors for CO, which can be assessed by evaluating patient characteristics using computed tomography, are described. Procedural factors associated with an increased risk of CO are discussed. Preventive techniques, including the chimney stent and bioprosthetic aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA), are also described, highlighting the advantages and disadvantages of each method. The present review also provides an overview of emerging dedicated devices designed to address this complication. In conclusion, identifying patients at risk for CO is crucial for optimizing TAVI outcomes. Comprehensive imaging assessment and appropriate preventive strategies, such as the BASILICA technique, can mitigate the risk of CO and improve patient outcomes. Further research is needed to validate emerging dedicated devices.
El cierre percutáneo de la orejuela izquierda (CPOI) se ha propuesto como una alternativa al tratamiento anticoagulante en pacientes con fibrilación auricular no valvular para disminuir el riesgo ...tromboembólico, evitando los riesgos de la anticoagulación. Esta opción puede ser atractiva en pacientes con fibrilación auricular no valvular y enfermedad renal crónica (ERC), ya que presentan un alto riesgo tanto tromboembólico como hemorrágico.
Determinar el papel pronóstico de la presencia de ERC en pacientes con fibrilación auricular sometidos a un CPOI periprocedimiento y durante el seguimiento comparado con los pacientes con función renal preservada.
Estudio retrospectivo, observacional de muestreo consecutivo que incluyó 124 pacientes sometidos a CPOI por fibrilación auricular en un hospital universitario y se compararon los resultados según la función renal basal.
La mediana de edad fue 75,5 años (RIQ 67,6-80), el 62,1% eran hombres, la mediana de CHA2DS2-Vasc y HASBLED era de 4 (RIQ 3-4) para ambas escalas. El 57,3% de la muestra tenía ERC. Las características basales eran similares entre ambos grupos, salvo una media de edad y un score de HASBLED superiores en los pacientes con ERC. Durante el procedimiento, no se observó ningún evento tromboembólico, de sangrado o muerte. Durante el tiempo de hospitalización y de seguimiento combinados, no hubo diferencias significativas entre grupos en la tasa anual de episodios tromboembólicos (0,97/100 pacientes-año 100PA vs. 4,06/100PA, p=0,092), pero si se observó una mayor tasa de sangrados (5,67/100PA vs. 13,3/100PA, p=0,033), y de mortalidad (6,50/100PA vs. 17,2/100PA, p=0,009) en el grupo de ERC, con una odds ratio para mortalidad de 2,711 (IC95% 1,96-6,95). En el análisis multivariante, el FGe preservado se asoció independientemente con una menor mortalidad.
El CPOI es una alternativa válida a la anticoagulación oral en pacientes con ERC y fibrilación auricular, con una baja tasa de eventos peri- y posprocedimiento. No obstante, los pacientes con ERC presentan mayor riesgo de sangrado y de mortalidad durante el seguimiento. Aunque estas mayores tasas no están necesariamente relacionadas con el procedimiento.
Percutaneous left atrial appendage closure (LAAC) has been proposed as an alternative to anticoagulation therapy in patients with nonvalvular atrial fibrillation to decrease the thromboembolic risk, while avoiding the risks of chronic anticoagulation. This option may be attractive in patients with nonvalvular atrial fibrillation and chronic kidney disease (CKD), since they exhibit both high-thromboembolic and bleeding risks.
To evaluate the prognostic impact of the presence of CKD in patients with atrial fibrillation undergoing LAAC peri-procedure and during the follow-up as compared with patients with preserved renal function.
Retrospective, observational study that included 124 consecutive patients with atrial fibrillation undergoing LAAC in a university hospital, and the results were evaluated according to the baseline renal function of the patients.
The median age was 75.5 years (IQR 67.6–80) and 62.1% were men, the median of CHA2DS2-Vasc and HASBLED scores was 4 (IQR 3–4) for both scores. Up to 57.3% of the total sample had CKD. Baseline characteristics were similar between groups, but CKD patients were older and had a higher HASBLED score. During the procedure, no thromboembolic, bleeding events, or deaths were observed. Combining the time of hospitalization and follow-up, no significant differences were observed between groups in the annual rate of thromboembolic events (0.97/100 patient-years 100PY vs. 4.06/100PY, p=.09), but there was a higher rate of bleeding events (5.67/100PY vs. 13.3/100PY, p=.033) and mortality among CKD patients (6.50/100PY vs. 17.2/100PY, p=.009), with an odds ratio of 2.711 (95% CI 1.96–6.95). In the multivariate analysis, a preserved eGFR was independently associated with a lower mortality risk.
LAAC is a valid alternative to oral anticoagulation in patients with CKD and atrial fibrillation, with a low-rate of peri- and post-procedure complications, although CKD patients exhibited a higher risk of bleeding and mortality during the follow-up. However, these higher rates may not be necessarily related to the procedure.
The inclusion of patients who are not at risk for this specific complication may have translated into a significant underestimation of the real incidence of PPM following TAVR, and introduces a major ...bias when informing patients about the real risks of PPM following the TAVR procedure. ...this study's objective was to estimate the "real" incidence of PPM following TAVR and to compare it with the incidence reported by the TAVR studies. Controversy still exists regarding the long-term impact of new PPM post-TAVR (2,3), but the short- and long-term risks and morbidity associated with PPM are well known (4,5). ...it would be important to consider these results in future TAVR studies especially with the shift towards implanting newer generation devices within lower-risk patients.
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